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NCT Number: NCT04261153

Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study

Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.

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Key information

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with breast cancer, aged 70 and over,
  • During treatment with chemotherapy, targeted therapy or radiotherapy.
  • Whatever the stage of the disease,
  • Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy
  • Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards),
  • Patient with education level 3 "end of primary education" minimum (Barbizet scale),
  • Mastery of the French language,
  • Patient who signed the consent to participate in the study.

Exclusion criteria

  • Hospitalization for neurological reasons (e.g. confusion), or psychiatric,
  • Documented brain metastases,
  • History of brain radiation therapy,
  • Progressive psychiatric pathology or known dementia,
  • Abuse of alcohol or drug use,
  • Severe visual and / or hearing loss,
  • Patient's refusal to participate,
  • Patient deprived of liberty or under guardianship.

Treatment and study plan

cognitive stimulation

Other

3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days

Primary outcomes

  1. Acceptance Rate

    Time frame: Between inclusion to 1 week

    Acceptance was defined as completing at least three exercises during the training time (10 minutes) during one of the two independent training sessions.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Centre Henri Becquerel

Registry information

Acronym: COG-TAB-AGE

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Feb 7, 2020
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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